Six University of Pennsylvania and Daniel J. Rader patents on Juxtapid (lomitapide) failed to discuss multiple NIH grants

On March 29, 2018, KEI asked the NIH to investigate the failure of the University of Pennsylvania and Daniel J. Rader to report NIH funding relating to 6 patents in the FDA Orange Book for the drug Juxtapid (INN lomitapide).… Continue Reading

Reasonable Pricing Clause

1994. The 1994 NIH Report on CRADAs and the Reasonable Pricing Clause 1994. September 8. James Love. Pricing of Drugs Developed with Public Funds. Comments Presented to the Second NIH CRADA Forum. 1995. April 11. NIH Notice Rescinding the Reasonable… Continue Reading

Failures to Disclose Bayh-Dole rights

KEI Briefing Note 2018:1. Bayh-Dole Obligations to Disclose Federal Funding Government oversight of under-reporting U.S. federal rights in patents. 1994. June 15, 1994, Inspector General Report to HHS on the under-reporting of federal funding of inventions at the Scripps Research… Continue Reading

KEI Appeals NIH/NCI Decision to Proceed with License of CD30 CAR T technology to Gilead/Kite

KEI has appealed the NIH/NCI decision to proceed with the proposed exclusive license of anti-CD30 CAR T to Gilead, following an email of January 25, 2018 from Dr. David Lambertson of NCI rejecting all of KEI’s substantive suggestions and objections. KEI… Continue Reading

Zinbryta

2017 KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis), September 15, 2017.

NIH Declines Request for the Budget for Clinical Trials Involving CAR T technology to be licensed to Kite/Gilead

On February 14, the NIH was asked what the budget was for the Phase 1 clinical trial of the anti-CD30 CAR T technology that is the subject of a proposed exclusive patent license to Kite/Gilead. The clinicaltrials.gov identifier for the… Continue Reading